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Inspire Medical Systems: Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry

Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in the clinical practice setting; 2) collect additional information on the effectiveness, use and safety in the commercial setting; and 3) engage physician customers to report the collective outcome within a group of properly trained programs that utilize Inspire therapy on a regular basis.

In addition, a sub-study will be conducted under this Registry at a limited number of Registry centers and will include a cohort of Registry patients and a cohort of patients who have not received the Inspire therapy device due to denial of insurance coverage. The two sub-study cohorts' quality of life and AHI data will be compared.

Inclusion Criteria:

Any patient implanted with or receiving an Inspire implant, who meets the following criteria, is eligible to participate in the registry:

  1. Capable of giving informed consent, as required per institution
  2. Willing to return for routine clinic visits as required for Inspire therapy management

Exclusion Criteria:

Any patient who meets any of the following criteria will not be eligible to participate in the registry

  1. Has a life expectancy of less than 1 year
  2. Any reason the clinician deems patient is unfit for participation in the study

For more information please call 502.893.0159 and ask for Research

 

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